2005N-0345 Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
FDA Comment Number : EC1390
Submitter : Ms. Susanne Clausnitzer Date & Time: 10/28/2005 03:10:51
Organization : Ms. Susanne Clausnitzer
Category : Individual Consumer
Issue Areas/Comments
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC drug product?
The Food and Drug Administration should simply approve without further delay over-the-counter (OTC) sale of emergency contraception - with no prescriptions required for any age group. This obviates the need for any new rulemaking. The two advisory FDA committees that exhaustively reviewed data in December 2003 found that emergency contraception was safe and effective and consequently recommended OTC approval.

More than 70 professional medical and public health associations including the American Medical Association, the American College of Obstetricians and Gynecologists and the Society for Adolescent Medicine have endorsed EC access for women of all ages. The American Academy of Pediatrics has urged its members to "help ensure that all adolescents have knowledge of and access to contraception, including barrier methods and EC supplies. Don't confuse age concerns with whether all women require access to safe medications.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Yes, but only because unnecessary age considerations have muddied the issue
C. If so, would a rulemaking on this issue help dispet that confusion?
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a matter of law?
This is a bad idea and an unnecessary intrusion into medical privacy. EC has been deemed medically safe - and this is the only responsibility of the FDA. Determining who can take advantage of this medically safe product is not in their jurisdiction.
B. If it could, would it be able to do so as practical matter and, if so, how?
No. Again, this would require unnecessary medical intrusion into the privacy of woman who don't need federal agents being concerned about their
medically safe private choices.
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?
Surely. Assure that EC is available to all and don't worry about the packaging.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
There are none.
Please make safe legally available EC medical treatments availabe to all women ASAP.